Pharma brand plan

Brand plan for Itraconazole. Insight on new product launch.

1. Itraconazole 100 & 200 mg Capsules

2. Brand Plan: Agenda Brief Summary Why Brintra ? Market Analysis Competitor Analysis Top Brands Analysis Inference On Competitors Competitors Positioning Competitors Positioning Inference SWOT Analysis Pathway From Inference Brintra : Suggested Positioning Indications Brintra : Revenue Forecast Brintra : Brand Strategy

3. Brief Summary Dermatologists across India has warned of “an epidemic of fungal infections” Indiscriminate use of topical steroid cream preparations is leading to fungal infections becoming resilient Fungal infections has become relapsing, recurrent and spreads easily 50 per cent of fungal infections are not reacting to conventional treatments I ncrease in the prevalence of dermatophytosis over the past 4–5 years across the country Anti-fungal market has 23% (1891 Cr) share in total derma market with CAGR of 31% Source: http://www.thehindu.com/opinion/op-ed/An-era-of-untreatable-skin-infections/article14621962.ece & ims quintiles April MAT

4. Why Brintra ? Brintra : Itraconazole 100 & 200 mg Capsules is the No. 1 prescribed drug in the anti-fungal segment Itraconazole has shown robust incremental growth with CAGR of 74% with 649 Cr from FY 2014 to 2018 Itraconazole contributes to 8% of market share in total dermatology segment in India Itraconazole is the No. 1 prescribed single/monotherapy drug in dermatology segment Dermatophytosis is ranked No. 1 in indication seen by dermatologists in which Itraconazole is the only oral drug preferred Itraconazole is prescribed by derma, GP, Non-MBBS and Gynecs which resulted in strong sale volume Source: ims quintiles April MAT 2018

5. Market Analysis Value in IPM 649 Cr 5Ys CAGR in IPM 74% Market Share to AF Segment (1891 Cr) 31% Itraconazole Sales Analysis Source: ims quintiles April MAT 2018 Incremental growth with CAGR of 74% with 649 Cr from FY 2014 to 2018 Itraconazole market share is 34% to the total anti-fungal market in India

6. Market Analysis Dermatophytosis Rx Analysis By Dermats Rx Share 19% Total Derma Rx 415 Lacs Rx By Derma 78 Lacs Dermatophytosis is the top indication seen by Dermats where Itraconazole ranked 1 among prescribed drugs Dermatophytosis accounts to 19% of Rx share by dermats Source: TSA MAT March’ 17 & Rx MAT Feb’ 17

7. Market Analysis Dermatophytosis + Fungal Infections Rx Analysis By GPs Rx Share 31% Total Derma Rx 345 Lacs Rx By GPs 105 Lacs Fungal Infections & Dermatophytosis is the top indications seen by GPs where Itraconazole ranked 1 among prescribed drugs Fungal Infections & Dermatophytosis accounts to 31% Rx share by GPs Source: TSA MAT March’ 17 & Rx MAT Feb’ 17

8. Market Analysis Itraconazole Rx Analysis Vs Others Itraconazole has seen a good progress in derma Itraconazole Rx CAGR growth for 4 yrs is 81% second leading to Luliconazole but leads with 43 Lacs Rx CAGR in Rx 81% Rx by Derma 43 Lacs (No. 1 AF) Source: TSA MAT March’ 17 & Rx MAT Feb’ 17

9. Market Analysis Itraconazole SKUs 100 mg value is 245 Cr with CAGR of 34% 200 mg value is 391 Cr with CAGR of 274% 200 mg is expected to become 650 Cr in 2019 with current growth rate It is ideal to launch Itraconazole 100 mg & 200 mg Capsules 100 mg 245 Cr @ 38% MS 400 mg 9.2 Cr @ 1.4% MS 200 mg 391 Cr @ 60% MS Source: ims quintiles April MAT 2018

10. Competitor Analysis Itraconazole launch of new brands where seen sudden surge in last three years due to increase prevalence in dermatophytosis infections In 2017 & 2018 139 SKUs has been launched in Itraconazole market with sale value of 163 Cr and this incremental sale is because of new brands and SKUs 44 new brands of Itraconazole 200 mg & 31 Itraconazole 100 mg has been launched in 2017 ITRAGREAT has recorded 4.63 Cr in the first year, followed by ITRANOX with 3.83 Cr, & ITRAZOLE 3.35 Cr. ITASPOR & IT-MAC launched 200 mg 1 X 8s pack which capitalized 18.72 Cr & 18.40 Cr respectively Only ITRAGREAT has recorded 2.35 Cr in the first year & other brands where less than a Cr ITASPOR launched 100 mg 1 X 8s pack which capitalized 11.48 Cr in a year IT-MAC launched 100 1 X 10s pack which capitalized 8.75 Cr in a year It is evident that Itraconazole 100 mg & 200 mg could be launched as per the market. 400 mg market is least with 9.2 Cr and fungal infections respond well with Itraconazole 100 & 200 mg , hence 400 mg will not be ideal to launch Dusting powders value is insignificant and mixed response revealed by dermats in causing resistance Source: ims quintiles April MAT 2018

11. Competitor Analysis Itraconazole 200 mg Brands FY 2018 FY 2017 FY 2016 Value in Cr Gr % Value in Cr Gr % Value in Cr Gr % ITRACONAZOLE 200 MG 391.00 102.24 193.33 279.22 51.00 999.00 CANDIFORCE 73.53 74.37 42.17 115.37 19.60 970.56 IT-MAC 66.16 97.13 33.60 747.51 3.97 999.00 CANDITRAL 31.70 69.32 18.80 306.41 4.70 999.00 ITRASYS 27.01 14.59 23.60 130.89 10.21 999.00 SYNTRAN 24.90 77.07 14.03 260.59 3.90 999.00 I-TYZA 21.06 50.20 14.02 999.00 1.20 999.00 ITASPOR 20.21 28.57 15.72 151.47 6.26 999.00 B rands above 10 Cr value is considered for competitor analysis Top 7 brands contributes to 68% of total Itraconazole 200 mg value CANDIFORCE (Mankind) is ranked No. 1 in terms of value 73.53 Cr with growth of 74.37% followed by IIT-MAC ( Macleods) 66.16 Cr with growth of 97.13%. CANDIFORCE & IT-MAC has strong equation with GPs and Gynecs which adds an additional flow of business to derma ITRASYS (Systopic), I-TYZA (Abbott) & ITASPOR (Intas) are the brands having below 50% of growth rest other brands having more than 50% of growth Source: ims quintiles April MAT 2018

12. Itraconazole 1 00 mg Competitor Analysis Brands FY 2018 FY 2017 FY 2016 Value in Cr Gr % Value in Cr Gr % Value in Cr Gr % ITRACONAZOLE 100 MG 246.00 32.49 185.00 52.32 122.00 57.86 CANDIFORCE 38.95 -1.40 39.50 16.82 33.81 37.84 IT-MAC 29.28 58.70 18.45 335.41 4.24 999.00 ITRASYS 18.25 7.03 17.05 49.42 11.42 211.71 SYNTRAN 15.13 32.69 11.40 40.38 8.20 204.85 CANDITRAL 14.79 1.14 14.62 -12.98 16.80 5.73 SPORANOX 14.36 26.57 11.34 37.35 8.26 25.26 ITASPOR 12.60 4.68 12.04 -3.73 12.50 17.67 I-TYZA 11.49 -14.87 13.49 20.05 11.24 367.84 8 Brands above 10 Cr value is considered for competitor analysis Top 8 brands contributes to 63% of total Itraconazole 100 mg value CANDIFORCE is ranked No. 1 in terms of value 38.95 Cr with growth of -1.40% followed by IT-MAC 29.28 Cr with growth of 58.70%. IT-MAC, SYNTRAN & SPORANOX are the brands having double digit growth with IT-MAC records the highest growth 58.70% followed by SYNTRAN 32.69% & SPORANOX 26.57% CANDIFORCE & I-TYZA are in negative growth with I-TYZA records highest negative growth of -14.49% & CANDIFORCE -1.40% Source: ims quintiles April MAT 2018

13. Inference On Competitors 101 Itraconazole brands are available in the market 100 mg and 200 mg are the main SKUs of Itraconazole 92 brands are available in 100 mg and 85 brands are available in 200 mg 13 out of 101 brands contributes to 75% of the total sale value of Itraconazole with value of 487.25 Cr Macleods and Glenmark has 3 brands. Mankind, Lupin, Cipla and Sun has 2 brands in Itraconazole market Mankind (CANDIFORCE + ITRAGREAT) has the highest volume of Itraconazole with 121.79 Cr followed by Macleods (IT-MAC + ITRAGEN + MONOCAN) with 106.85 Cr and Glenmark (CANDITRAL + SYNTRAN + CANDITZ) WITH 97.21 Cr. Mankind, Macleods & Glenmark with 8 brands contributes to 50% volume of total Itraconazole sales 44 new brands of Itraconazole 200 mg & 31 brands of 100 mg has been launched in 2017 to 2018 which is highest number of new products in derma Itraconazole 400 mg and Dusting powders values are insignificant and mixed response revealed by dermats in causing resistance for powder

14. Competitors Price Analysis Itraconazole 200 mg Rs. 18 per capsule (ITRASYS) is the lowest and Rs. 35 is the highest (ITASPOR, SYNTRAN & CANDITRAL) Top brands in market like CANDIFORCE (Rs. 20), IT-MAC (Rs. 19.6) & ITRASYS (Rs. 18) has priced low, hence they effectively penetrates of price conscious dermats and mainly no-dermats like GPs and Gynecs Pricing is very important for new launch and low or at par price to CANDIFORCE, IT-MAC & ITRASYS is to be considered for captivating market share Source: ims quintiles April MAT 2018

15. Competitors Price Analysis Itraconazole 100 mg Rs. 10 per capsule (IT-MAC & CANDIFORCE) is the lowest and Rs. 81.25 is the highest (SPORANOX) Top brands in market like CANDIFORCE (Rs. 10), IT-MAC (Rs. 10) & ITRASYS (Rs. 12) has priced low, hence they effectively penetrates of price conscious dermats and mainly no-dermats like GPs and Gynecs Pricing is very important for new launch and low or at par price to CANDIFORCE, IT-MAC, ITRASYS & I-TYZA is to be considered for captivating market share Source: ims quintiles April MAT 2018

16. Competitors Positioning

17. Competitors Positioning Inference Positioning of a new Itraconazole brand need to be focused on two parameters: 1. New technology in formulation. 2. Price Advantage.

18. Big market size of 649 Cr with CAGR of 74% Itraconazole Rx CAGR growth for 4 yrs is 81% leading in derma Rx with 43 Lacs Itraconazole is prescribed by huge set of doctors like derma, GPs, Non-MBBS & Gynecs 101 brands are already available in the market Top 3 brands (CANDIFORCE, IT-MAC & ITRASYS) with low pricing strategy has 40% of market share Over crowded SKUs with increase in ambiguity Fungal disease is becoming epidemic with increase in prevalence in India. 30% case per day per dermat Increase in Resistant and recurrent fungal infections Unique formulation helps in drug effectiveness compared to existing brands Compliance / dose convenient pack for patients More number of me-too products will be launched with lesser price Generic variations of Itraconazole could be sold Government regulations like price barrier could be introduced SWOT Analysis: Itraconazole

19. Market size is big and significant market share can be achieved with correct product strategy It is must to consider in launching unique formulation which helps in drug effectiveness compared to existing brands Introducing compliance and dose convenient pack for patients will be an added value for gaining doctors attention because most brands are introducing 10s packing seen in the market Fungal infections in Indian is becoming epidemic, hence opportunity in anti-fungal segment will be a growth driver for a company, hence Itraconazole could be launched GPs and Non-MBBS should be educated in correct usage of Itraconazole and other anti-fungals and investing in their learning will increase our business opportunity Itraconazole new product could be launched in considering the following inferences: Way forward from Inference

20. Itraconazole: New Product Launch

21. Itraconazole 100 & 200 mg Capsules

22. Product Presentation Itraconazole 100 mg Capsules Itraconazole 200 mg Capsules Itraconazole 100 mg Capsules Itraconazole 200 mg Capsules 1 X 10s 10s X 1 Box 1 X 10s 10 X 1 Box Bottle of 30 Capsules Bottle of 30 Capsules BRINTRA… First time in India, Itraconazole is available in Bottles of 30 Capsules for dosing convenience

23. Rationale for Packing Source: ims quintiles April MAT 2018

24. Suggested Positioning

25. Proof of Product Claim BRINTRA Generic Itraconazole Source: https://www.isdin.com/en/infections/itragerm/

26. Because of low solubility and high permeability Itraconazole suffer from poor aqueous solubility which results in poor dissolution rate in the GI tract and may compromise oral bioavailability. Positioning Rationale Enhancement of dissolution rate of Itraconazole after oral administration was one of the most challenging aspects in pellet formulation. Because of low solubility and high permeability Itraconazole suffer from poor aqueous solubility which results in poor dissolution rate in the GI tract and may compromise oral bioavailability. Few strains of dermatophytes are resistant to generic Itraconazole due to insufficient bioavailability because of poorly soluble and highly variability Few clinical cases of aspergillosis are reported globally were replacement Sporanox with generic itraconazole resulted in treatment failure due to inadequate plasma levels of Itraconazole and even development of resistance BRINTRA reduces intra-and inter-patient variability and enables more predictable clinical response. SDP improves bioavailability & 3X increase in absorption 2 4 5 3 1 Super Bioavailable Itraconazole with SDP Technology Predictable Clinical Response in 3R Fungal Disease

27. Product Details

28. Indications & Dosage Due to Resistant, Refractory & Recurring fungal infections the recommended dosages are not sufficient for treatment. Inter/ intra-patient variability makes recommended dosage unpredictable Dermats clinically in practice recommend Itraconazole with other topical anti-fungals till infection resolves. Dermats see more refractory and recurring cases in same patients which clinically required more days for resolution of infection.

29. First Year SKUs PCPM (175 MRs) PTD PCPM Value Brintra 100 mg 10s 50 108 5400 Brintra 200 mg 10s 50 180 9000 Brintra 100 mg Bottle 25 324 8100 Brintra 200 mg Bottle 25 540 13500 PCPM Value / MR 36000 Sale in Value (Company) 75600000 Sales Forecast BRINTRA First 3 Years Sales Forecast Second Year SKUs PCPM (175 MRs) PTD PCPM Value Brintra 100 mg 10s 70 108 7560 Brintra 200 mg 10s 70 180 12600 Brintra 100 mg Bottle 40 324 12960 Brintra 200 mg Bottle 40 540 21600 PCPM Value / MR 54720 Sale in Value (Company) 114912000 Third Year SKUs PCPM (175 MRs) PTD PCPM Value Brintra 100 mg 10s 100 108 10800 Brintra 200 mg 10s 100 180 18000 Brintra 100 mg Bottle 60 324 19440 Brintra 200 mg Bottle 60 540 32400 PCPM Value / MR 80640 Sale in Value (Company) 169344000 BRINTRA sale projected in first year is 7.56 Cr, second year 11.49 Cr & in third year 16.93 Cr. 50% growth is considered compared to CAGR 74% of the market As a strong focus in derma PCPM of CANDITRAL(100 mg-383/200 mg-456), SYNTRAN (100 mg-385/200 mg-337) & ITASPOR (100 mg-343/200 mg-352) is considered for PCPM derivation. Source: ims quintiles April MAT 2018

30. Brand Strategy 2 4 5 3 1 SDP Technology Communication Super Bioavailability 3X Increase in absorption Reducing intra-and inter-patient variability to enable predictable clinical cure rate 3Rs Fungal Infections Communication Communication & positioning on Resistant, Refractory & Recurrent Fungal Infections Special campaign on BRINTRA against Trichophyton in diabetics Bottles Compliance Packing Focus Communicating bottle packing for dosing & patient compliance Creating niche space for dermats to try new packing variant Non-Dermats Education GPs & Non-MBBS activities in educating on rationale use of anti-fungals Activity to reduce steroid modified fugal infections Awareness Activities Patient awareness activities is much needed as insist by dermats Creating brand awareness in conferences Sales promotional activities to be deployed in first year

31. Brand Strategy For Qtr 1

32. Brand Strategy For Qtr 2

33. Brand Strategy For Qtr 3

34. Brand Strategy For Qtr 4

35. Brand Strategy Product launch to the field force need to be unique & KOLs should be called during product launch to learn Rx behaviours Inflatable ball to show super bioavailable Itraconazole Palm Scanner to unveil the product Product launched through drone

36. Execute…Brand Plan Prepared By: K. Varun Ramkumar Brand Manager